Monday, April 22, 2013

The parties compete in the market for progesterone
supplements used for in vitro fertilization/assisted reproductive technology
(ART).The traditional method of
supplementation is through intramuscular injections, but the parties’ products
(Endometrin and Crinone, respectively) are vaginal inserts to supplement or
replace daily intramuscular shots. Endometrin is a capsule applied two or three
times a day, while Crinone is a gel delivered via applicator once daily. There
are no other FDA-approved vaginal inserts.

Ferring sued Watson over ads allegedly painting Endometrin
as dangerous, not effective, disliked by consumers, and inferior to
Crinone.Watson hosted and invited
doctors and healthcare professionals to two events (in-person and webcast) on
September 11, 2012, at which Dr. Silverberg, a paid Watson consultant, detailed
the qualities and success rates of Crinone in an effort to influence attendees
to purchase the product. Silverberg’s
key claims were (1) reference to a “Black Box warning” on Endometrin; (2) that
patients preferred Crinone; and (3) that Endometrin hasn’t been proven
effective for women over 35.

During one webcast, Silverberg indicated that “if you read
the package insert for Endometrin there is a Black Box warning showing the
efficacy has not been demonstrated with [ ... ] Endometrin for patients 35
years of age and older.” Though the packaging does state that efficacy in women
35 and older hasn’t been clearly established, Endometrin doesn’t have a Black
Box warning.A Black Box is the
strongest warning required by the FDA, and signifies that medical studies
indicate the drug carries a significant risk of serious or life-threatening
adverse effects. Silverberg, informed of
the error, didn’t repeat this misstatement on the second webcast and certified
that he wouldn’t repeat it in the future.

Silverberg also said that, comparing Crinone to Endometrin
based on a phone survey, 94% of patients thought that Crinone was easier to
incorporate into their daily lifestyle, and gave similarly high percentages for
comparative convenience/comfort.Ferring
argued that there was no evidence that the women interviewed used both products
and were therefore able to compare the two; the percentages were instead just
percentages of women who liked CrinoneOther women in the study allegedly liked Endometrin, but Silverberg didn’t
report those results.Ferring contended that this was not a head-to-head
comparative study, despite Silverberg’s claims, which therefore allegedly
violated FDA requirements for making preference claims about pharmaceuticals.Watson conceded that the percentages were
inaccurate, and the survey showed 68.1% preference, but argued that the survey
was in fact head-to-head.

Silverberg also said in one session that Crinone, unlike
other products, had been established in women 22-47, including women 35 and
older.Ferring argued that the studies
he cited didn’t stand for that proposition. At the same time, he said that Endometrin
“was not found to be efficacious for women over the age of 35.” Watson
disagreed about the meaning of the data.

The court denied Ferring’s motion for a preliminary
injunction for want of showing likely irreparable harm.Ferring argued that information on the
internet was likely to endure and continue to do harm, but Silverberg agreed
that he misstated the black box warning and removed it for his second webcast,
and certified that he wouldn’t say it again.Further, at Watson’s request, in future presentations he’ll only make
specified statements as to the efficacy of Endometrin for women over 35, in
accordance with the package insert.Ferring didn’t show that the webcasts were still available online.

The court then briefly considered likely success on the
merits, though it didn’t have to do so.While a completely unsubstantiated ad claim is literally false without
further affirmative evidence from the plaintiff, Novartis Consumer Health, Inc.
v. Johnson & Johnson–Merck Consumer Pharm. Co., 290 F.3d 578 (3d Cir.2002),
it wasn’t clear that the claim at issue here was “completely unsubstantiated.”
Rather, Watson showed that there was at least some support for the claims.(As establishment claims, they could be
falsified by showing that the evidence didn’t in fact support them—but that’s
an issue for later.)

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